1、September 2014 Translation by DIN-Sprachendienst.English price group 7No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.060.25!%:I|“2233889www.din.deDDIN EN ISO 16635-1Dentistry Dental rubber dam technique Part 1: Hole punch (ISO 16635-1:2013);English version EN ISO 16635-1:2014,English translation of DIN EN ISO 16635-1:2014-09Zahnheilkunde Kofferdamtechnik Teil 1: Lochzangen (ISO 16635-1:2013);Englische Fassun
3、g EN ISO 16635-1:2014,Englische bersetzung von DIN EN ISO 16635-1:2014-09Mdecine bucco-dentaire Technique de la digue dentaire en caoutchouc Partie 1: Pinces percer la digue (ISO 16635-1:2013);Version anglaise EN ISO 16635-1:2014,Traduction anglaise de DIN EN ISO 16635-1:2014-09SupersedesDIN 13993-1
4、:2009-05www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1008.14 DIN EN ISO 16635-1:2014-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16635-1:2014) has been prepared by Technical Committee ISO/
5、TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-23 AA Den
6、talmedizinische Instrumente. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 6507-1 DIN EN ISO 6507-1 ISO 6508-1 DIN EN ISO 6508-1 Amendments This standard differs from DIN 13993-1:2009-05 as follows: a) the con
7、tent of DIN 13993-1:2009-05 has been adopted in ISO 16635-1:2013; b) steel designations have been specified in accordance with ISO 15510; c) tolerances for hole diameters have been reduced to 0,1 mm. Previous editions DIN 13993-1: 2009-05 National Annex NA (informative) Bibliography DIN EN ISO 1942,
8、 Dentistry Vocabulary DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method DIN EN ISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16635-1 April 2014
9、ICS 11.060.20 English Version Dentistry - Dental rubber dam technique - Part 1: Hole punch (ISO 16635-1:2013) Mdecine bucco-dentaire - Technique de la digue dentaire en caoutchouc - Partie 1: Pinces percer la digue Zahnheilkunde - Kofferdamtechnik - Teil 1: Lochzangen (ISO 16635-1:2013) This Europea
10、n Standard was approved by CEN on 25 April 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concer
11、ning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into
12、 its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Ge
13、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE
14、FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16635-1:2014 E(ISO 16635-1:2013) Contents Page DIN EN ISO 16635-1:2014-09 EN ISO 16635-1:2014 (E)
15、2 Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .6 4.1 General 6 4.2 Total length .6 4.3 Distance between the forceps handles in the open passive state .6 4.4 Characteristics of the die plate 7 4.5 Distances 7 4.6 Spring type mechanism 7 4.7
16、Materials .8 4.8 Surface profile and finish 8 5 Test methods 8 5.1 Visual examination 8 5.2 Dimensions .8 6 Marking .8 Foreword The text of ISO 16635-1:2013 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (ISO) and has been taken
17、over as EN ISO 16635-1:2014 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2014, and conflicting nati
18、onal standards shall be withdrawn at the latest by October 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-
19、CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary
20、, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16635-1:2013 has been approved by CEN as EN ISO 16635-1:2014 without any
21、modification. DIN EN ISO 16635-1:2014-09 EN ISO 16635-1:2014 (E) 3 IntroductionIn order to facilitate the use of dental rubber dam, standardization of the required instruments and materials is necessary.In dental practice hole punches do not come into direct contact with the patient, provided they a
22、re used as intended.DIN EN ISO 16635-1:2014-09 EN ISO 16635-1:2014 (E) 4 1 ScopeThis part of ISO 16635 specifies requirements and test methods for hole punches for dental rubber dam.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and ar
23、e indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodIS
24、O 6508-1, Metallic materials Rockwell hardness test Part 1: Test methodISO 15510, Stainless steels Chemical composition3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1dental rubber damdental damrubber damsheet of elasti
25、c material used for the isolation of one tooth or several teeth from the rest of the oral cavity3.2dental rubber dam clampfixation aid adapted to the form of the respective tooth, usually made of spring steel and consisting of two clamp jaws closely fitting the contour of the tooth and linked with e
26、ach other by means of one or two bow(s)Note 1 to entry: Usually, the clamp jaws have one hole each through which they can be grasped and fixed by means of a clamp forceps.3.3clamp forcepsforceps used for the placement and removal of dental rubber dam clampsNote 1 to entry: For this purpose, a clamp
27、is grasped by inserting the two retaining pins of the clamp forceps into the holes of the clamp jaws; the clamp is then tensioned and fitted to the tooth in the desired position.3.4hole punchforceps used to punch holes of different diameters in the dental rubber damDIN EN ISO 16635-1:2014-09 EN ISO
28、16635-1:2014 (E) 5 3.5punch handlegripping end for grasping and operating the hole punch3.6die platerotary plate engaging in defined positions and having holes of different sizes3.7die plate engagement mechanismmechanism at the die plate ensuring the engagement of that plate in defined positions3.8p
29、unchtapered working end of the hole punch designed to perforate the dental rubber dam by penetrating into the holes of the die plate3.9perforation pointpoint where the punch makes contact with the dental rubber dam on the die plate3.10insertion openingopening between the punch and the die plate3.11i
30、nsertion depthdistance between the punch and the hinge assembly, where the dental rubber dam can be inserted into the punch forceps4 Requirements4.1 GeneralThe purpose of the hole punch for dental rubber dam is the exact punching of holes of different sizes in dental rubber dam of different types an
31、d thicknesses.A mechanical arrangement shall be provided which ensures: a) automatic opening of the hole punch (e.g. by a spring); b) exact positioning of the holes of the die plate below the punch.Test in accordance with 5.1.4.2 Total lengthThe total length of the hole punch for dental rubber dam s
32、hall be (165 5) mm.Test in accordance with 5.2.4.3 Distance between the forceps handles in the open passive stateThe distance between the punch handles in the open passive state shall not exceed 95 mm.NOTE This ensures safe handling also by people with small hands.Test in accordance with 5.2.DIN EN
33、ISO 16635-1:2014-09 EN ISO 16635-1:2014 (E) 6 4.4 Characteristics of the die plateThe die plate shall have six holes ranging in size from 0,8 mm to 2,3 mm in diameter or eight holes ranging in size from 0,5 mm to 2,6 mm in diameter, with approximately the same increments (see Table 1 and Figure 1).T
34、est in accordance with 5.2.Table 1 Hole sizes for die platesDimensions in millimetresTolerances: 0,1 mmDie plate with 6 holes Die plate with 8 holes 0,50,8 0,81,1 1,11,4 1,41,7 1,72,0 2,02,3 2,3 2,6Figure 1 Die plates and hole sizes4.5 DistancesThe insertion depth shall be in the range from 20 mm to
35、 70 mm.NOTE This allows the dental rubber dam or a special dental rubber dam frame combination to be inserted deep enough in order to punch holes at any desired position.Test in accordance with 5.2.4.6 Spring type mechanism4.6.1 Spring type mechanism for holding the hole punch openIn its passive sta
36、te, the hole punch for dental rubber dam shall be opened, by means of a spring type mechanism, wide enough to ensure a distance of at least 2,5 mm between the tip of the punch and the face of the die plate.Test in accordance with 5.2.DIN EN ISO 16635-1:2014-09 EN ISO 16635-1:2014 (E) 7 4.6.2 Die pla
37、te mechanism for the engagement of the die plateThe die plate shall be provided with a mechanism which ensures its engagement in defined positions in order that the punch always makes contact with the holes at their centres.NOTE This is usually achieved by means of a spring mechanism.Test in accorda
38、nce with 5.1.4.7 MaterialsThe hole punch shall be made of corrosion resistant martensitic stainless steel 4021-420-00-I (X20Cr13) and 4034-420-00-I (X46Cr13) in accordance with ISO 15510.The die plate shall have a hardness of 48 HRC to 55 HRC or a Vickers hardness of 600 HV1 to 720 HV1.Test the Rock
39、well hardness in accordance with ISO 6508-1, scale C, or test the Vickers hardness in accordance with ISO 6507-1.4.8 Surface profile and finishThe surface profile is at the discretion of the manufacturer.The surfaces of the hole punch for dental rubber dam shall be free of pores, cracks, scale resid
40、ues, acidic fats and residues of abrasives and polishing agents.The surfaces of the working ends and the shafts shall be polished. A possible gloss is at the discretion of the manufacturer.Test in accordance with 5.1.5 Test methods5.1 Visual examinationPerform the examination of the hole punch with
41、normal visual acuity without any magnification.5.2 DimensionsTest the dimensions with usual length measuring devices with a maximum permissible error of 0,1 mm.NOTE Usual length measuring devices include external micrometers and callipers.The applied measuring force shall not exceed 1,5 N.6 MarkingThe hole punch shall be marked as follows:a) name of the manufacturer and/or brand;b) model number (reference number);c) lot number.DIN EN ISO 16635-1:2014-09 EN ISO 16635-1:2014 (E) 8
